BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ACUTE CARE SYSTEM

    MDR report key: 3911549 · Received June 20, 2014

    Report

    Report Number
    9611500-2014-00040
    Event Type
    Injury
    Date Received
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    MHX
    PMA / PMN Number
    K092788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS ASKED FOR FURTHER DETAILS BUT COULD NEITHER IDENTIFY THE CONCERNED MONITOR NOR THE USED BLOOD PRESSURE TRANSDUCER NOR THE DATE OF EVENT; THEREFORE, NO LOGS COULD BE DOWNLOADED AND NO INVESTIGATION COULD BE PERFORMED. OBSERVED ERROR POSSIBLY POINTS TO A PROBLEM OF FLUID INGRESS TO THE "INFINITY MCABLE-DUAL HEMO" (THE BLOOD PRESSURE TRANSDUCER) IN CASE OF WRONG HANDLING. THE ISSUE OF CORRECT HANDLING WAS ADDRESSED VIA A SAFETY NOTICE IN DECEMBER 2012 (B)(4). CUSTOMER REPORTED THAT THEY KNOWN THE SAFETY NOTICE BUT CANNOT SAY IF HANDLING OF THE "INFINITY MCABLE-DUAL HEMO" HAS BEEN CORRECT IN THE REPORTED CASE. SINCE PUBLICATION OF THE MENTIONED SAFETY NOTICE NO OTHER INCIDENT (INJURY OR MEDICAL INTERVENTION) HAS BEEN REPORTED IN COHERENCY WITH FLUID INGRESS TO THE "INFINITY MCABLE-DUAL HEMO."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: A PATIENT IN ICU WAS MONITORED WITH IACS AND INVASIVE BLOOD PRESSURE (IBP) WAS CONTINUOUSLY MEASURED BESIDE OTHER PARAMETERS. IT WAS RECOGNIZED THAT IBP WAS SIGNIFICANT LOWER THAN NIBP AND FOLLOWING THE IBP READING MEDICATION WAS GIVEN AGAINST HYPOTONIA. THE PATIENT SHOWED ALREADY CARDIAC ARRHYTHMIA. FINALLY WRONG IBP MEASUREMENT WAS IDENTIFIED. NO PERMANENT DAMAGE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362471 INFINITY ACUTE CARE SYSTEM PATENT MONITORING, MULTI PARAMETER MHX DRAEGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention